On May 25, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported the signing of a Master Supply Agreement for the therapeutic radioisotope copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAY 25, 2021, View Source [SID1234580503]). Under the agreement, NorthStar will supply Cu-67 exclusively to Clarity Pharmaceuticals as an active pharmaceutical ingredient used to support Clarity’s Targeted Copper Theranostics (TCT) programs.

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Cu-67 is a beta-emitting radioisotope with clinical applications as a radiopharmaceutical to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease.

"Previously, the lack of an effective copper chelating technology has limited the clinical development of Cu-67 products and subsequent commercial production of Cu-67," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Clarity Pharmaceuticals’ unique copper-chelating technology has enabled it to advance its product pipeline into a range of theranostic clinical trials that use copper-64 (Cu-64) for diagnostic imaging and Cu-67 as therapy. NorthStar is addressing the need for reliable Cu-67 radioisotope supply by advancing towards commercial-scale production. Our efforts use the proven expertise and innovative approach demonstrated in the successful development and commercialization of U.S.-produced, non-uranium molybdenum-99 (Mo-99) to generate technetium-99m. NorthStar is pleased to sign this agreement with Clarity Pharmaceuticals, and we look forward to supporting its plans for further clinical development and commercialization of Cu-67 based therapeutic radiopharmaceuticals to improve the lives of patients with serious disease."

"Consistent with other NorthStar production processes, the Cu-67 production process is also environmentally friendly and non-uranium based," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar Medical Radioisotopes. "Cu-67 has an optimal half-life for a therapeutic radiopharmaceutical, is produced domestically in the United States without a nuclear reactor, has no long-lived contaminants or bi-products from the manufacturing process, and its starting material, zinc, is readily available. As opposed to other therapeutic isotopes in the market and under development, Cu-67 is ideally suited for commercial production to meet the growing demand for radiopharmaceuticals in large disease indications and we look forward to meeting Clarity’s anticipated future demands as it develops and commercializes its suite of products."

"Clarity leads the world in the development and commercialization of TCT," said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. "Access to large, commercial supply of Cu-67 at a suitable price-point enables us to apply our TCT approach not only to rare diseases such as neuroblastoma in children, but also other cancers with very large patient populations such as prostate and breast cancers. In essence, the availability of large scale production of Cu-67 in the United States will increase the speed of Clarity’s clinical trials across our SARTATETM, SAR-bisPSMA, SAR-Bombesin and discovery programs and will help us to achieve our ultimate goal of better treating children and adults with cancer."

About Copper-67 (Cu-67)

Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope that is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian, and bladder cancers. A chelator, which strongly binds Cu-67 to the targeting agent, is required to develop safe and effective targeted therapies. Clarity has successfully developed a highly specific and highly stable chelator for copper isotopes and is progressing a range of radiopharmaceuticals based on its proprietary SAR Technology Platform. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment purposes.

On May 25, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAY 25, 2021, View Source [SID1234580522]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from May 17, 2021 to May 21, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 247,006 shares as treasury shares, corresponding to 0.38% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On May 25, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported that the Company will present at the following upcoming investor conferences (Press release, Fate Therapeutics, MAY 25, 2021, View Source [SID1234580540]):

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Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021, at 1:00 p.m. ET
BofA Securities 2021 Napa Biopharma Virtual Conference on Tuesday, June 15, 2021, at 5:30 p.m. ET
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

On May 25, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported it has entered into a multi-program research collaboration and license agreement with Genentech, a member of the Roche Group, to discover, develop and commercialize locally delivered respiratory and ophthalmology therapies that leverage Pieris’ proprietary Anticalin technology (Press release, Pieris Pharmaceuticals, MAY 25, 2021, View Source [SID1234580556]).

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The research collaboration will enable Pieris to combine its robust discovery engine with Genentech’s targets, as well as its preclinical and clinical development expertise, to create novel therapies for the treatment of respiratory and ophthalmological diseases. These two focus areas of the collaboration are uniquely suited to the advantages offered by the small size of Anticalin proteins when delivered locally.

"We look forward to working closely with Genentech on the development of new inhaled and ophthalmological treatments based on the Anticalin platform. This collaboration further expands our partnered efforts in respiratory diseases and opens a new avenue for our Anticalin technology to potentially provide patient benefit through local biological effects. This is our second respiratory alliance with a major biopharma company, and we remain deeply committed to inhaled biologics, which have already shown benefit in the clinic. We also look forward to pursuing another local application of our technology in ophthalmology, where Genentech has extensive capabilities," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

"Genentech has a longstanding commitment to understanding the underlying biology of respiratory and ocular diseases and translating this expertise into treatments for patients," said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. "We are excited to partner with Pieris Pharmaceuticals to advance potential new therapies that we hope could make a significant difference in the lives of people who need them."

Under the terms of the agreement, Pieris will receive $20 million as an upfront payment and may be eligible to receive more than $1.4 billion in additional milestone payments across multiple programs, as well as tiered royalties for commercialized programs. Pieris will be responsible for discovery research and early preclinical development of the programs, and Genentech will be responsible for IND-enabling activities, clinical development, and commercialization of those programs. Genentech will also have the option to select additional targets in return for an option exercise fee. The collaboration does not include any of Pieris’ internal programs.

On May 25, 2021 -Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with GT Medical Technologies, Inc., to develop Tumor Treating Fields (TTFields) together with GT Medical Technologies’ GammaTile Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent glioblastoma (GBM) (Press release, NovoCure, MAY 25, 2021, View Source [SID1234580572]). Novocure’s TTFields are electric fields that disrupt cancer cell division. GammaTile is an FDA-cleared therapy for the treatment of all types of brain tumors.

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"Our collaboration with GT Medical Technologies is an exciting and important opportunity to test the radio-sensitizing effect of Tumor Treating Fields, which will be applied for at least two weeks prior to resection and GammaTile implantation," said William Doyle, Novocure’s Executive Chairman. "This trial is designed to build additional evidence of the effectiveness of Tumor Treating Fields plus radiation therapy and to explore the potential to further extend survival for recurrent GBM patients."

Novocure and GT Medical Technologies plan to conduct a phase 2 pilot study to test the effectiveness and safety of neo-adjuvant TTFields followed by resection, GammaTile Therapy, and adjuvant TTFields for recurrent GBM. The study is designed to enroll approximately 55 patients in the United States. Progression free survival (PFS) for the intent-to-treat population is the primary endpoint of the study. Secondary endpoints include overall survival, PFS for per protocol patients, time to progression, six-month survival rate, one-year survival rate, PFS at six months, and safety.

"GT Medical Technologies is enthusiastic about the potential of these combined therapies," said Matthew E. Likens, President and CEO of GT Medical Technologies. "This trial is a great opportunity to expand care and therapeutic options for recurrent GBM patients. GammaTile delivers 50 percent of the radiation within 10 days of resection, which we believe maximizes patient outcomes while improving local tumor control and access to care. We are pleased to partner with Novocure in this pursuit."

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.